Decision Date2016-01-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Bovie Disposable Bipolar Ablator is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bovie Disposable Bipolar Ablator?
Bovie Disposable Bipolar Ablator is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Bovie Medical Corporation. The 510(k) number is K152777.
When did Bovie Disposable Bipolar Ablator receive FDA 510(k) clearance?
Bovie Disposable Bipolar Ablator received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152777.
Who is the listed applicant for Bovie Disposable Bipolar Ablator?
The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bovie Disposable Bipolar Ablator?
The FDA product code for Bovie Disposable Bipolar Ablator is GEI.
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Other records listing Bovie Medical Corporation as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.